FDA Greenlights Ekterly: A Groundbreaking Oral Treatment for Hereditary Angioedema Attacks
The FDA has granted approval to Ekterly (sebetralstat), a product of KalVista Pharmaceuticals. This marks a significant milestone as the first and only oral on-demand treatment for hereditary angioedema (HAE) attacks in adults and children aged 12 years and older. This approval, announced on July 7, 2025, represents a significant breakthrough for patients with this rare genetic disease.
HAE is a condition that affects approximately 1 in 10,000 to 1 in 50,000 people worldwide. It causes unpredictable, painful episodes of swelling in various parts of the body. Unlike existing treatments that require injections, Ekterly comes as an oral tablet. This allows patients to take the medication at the earliest sign of an attack, providing greater convenience and faster treatment initiation.
The approval of Ekterly was based on results from the phase 3 KONFIDENT clinical trial. The trial showed that 50% of patients treated with the 600 mg dose achieved complete attack resolution within 24 hours. The drug is priced at $16,720 per dose and will be available immediately through specialty pharmacies.
Source: KalVista Pharmaceuticals